Abstract
Background: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been demonstrated to significantly reduce the risk of recurrent adverse vascular events in high-risk patients with a history of coronary, cerebral, or peripheral artery disease. The primary barrier to the use of these drugs is their cost. Use of these drugs in the highest-risk patients would improve their cost-effectiveness. A clinical guidance for the use of these drugs based on vascular risk was recently published.
Objectives: To determine how clinical guidance recommendations would impact the numbers of patients eligible to receive PCSK9 inhibitor therapy.
Methods: 2000 consecutive patients admitted to an academic medical center referred to a cardiology consult service with documented atherosclerotic cardiovascular disease (ASCVD) were evaluated for PCSK9 inhibitor eligibility using the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) clinical guidance recommendations. Any patient with ASCVD with an LDL-C >140 mg/dl was considered eligible for PCSK9 inhibitor therapy. Patients with an LDL-C >100 mg/dl had to meet additional criteria to be eligible. These criteria included (1) diabetes with target organ damage or another risk factor; (2) severe or extensive CAD; or (3) progressive/accelerated ASCVD, ischemic stroke, or revascularization in the coronary, cerebral, or peripheral arterial system within 2 years of a previous ASCVD event.
Results: Mean age was 64.9 ± 12.7 years; 66% were men and 34% were women; 80% were white, 9% were black, 10% were Latino and 1% other. Eligibility for PCSK9 inhibitor therapy included 163 patients with LDL-C >140 mg/dl and 892 patients with LDL-C >100 mg/dl with additional risk factors. Additional risk factors were diabetes plus comorbidity in 318 patients; severe or extensive CAD in 317 patients; and progressive/accelerated ASCVD in 257 patients. The total number of patients eligible for PCSK9 inhibitor therapy using the ESC/EAS criteria was 1055 (53%).
Conclusions: Previous studies have estimated 15 to 25% of patients with a history of vascular disease to be eligible for PCSK9 inhibitors. In this high-risk cardiac population, over 50% of patients would be PCSK9 inhibitor eligible. The cost to treat this proportion of patients would represent an overwhelming burden to any health system using current drug costs. Medication access coordinators need to play a critical role in the selection and evaluation of patients eligible for PCSK9 inhibitor therapy to maximize cost-efficiency of this therapy.